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State Laws Could Cover DTC Gene Testing

NEW YORK (GenomeWeb News) – While the US government considers whether or not it will draft policies to regulate the marketing of direct-to-consumer genetic testing through panels and working groups, the Genetics and Public Policy Center at Johns Hopkins University has taken a look at state laws to find out if they would cover such advertising.

GPPC commissioned Georgetown University to conduct a survey of state false advertising laws to find out if any states had laws that deal directly with genetic testing advertising, or if their laws could include these tests. The survey found that no states currently have any laws that deal specifically with advertising direct-to-consumer genetic tests, but it also found that all states have laws that could cover these tests.

Two states, California and Nevada, specifically have laws prohibiting false or misleading scientific or clinical assertions, the researchers found. They also found that two other states, Pennsylvania and Nebraska, explicitly prohibit false or misleading statements about privacy policies.

Twenty states have adopted a measure called the Uniform Deceptive Trade Practices Act, which says that it is a deceptive trade practice to "represent that goods or services have sponsorship, approval, characteristics, ingredients, uses, benefits, or quantities that they do not have," according to GPPC.

Fourteen states have laws saying that it is illegal to fail to state a "material fact" about a product or service, while 28 states have provisions against misrepresentation of goods or misleading practices.

"These statutes are broad enough to encompass DTC genetic testing products and services, but the complexity of DTC genetic testing products and services may make application of such laws challenging," GPPC said in the report. "The survey identified no actions against DTC genetic testing companies that had been undertaken based on these general laws, although the attorney general in one state did undertake an investigation against one company advertising genetic testing directly to the public."

At the federal level, the Department of Health and Human Services continues to examine the genetic testing field, and the Secretary's Advisory Committee on Genetics, Health, and Society currently is reviewing a set of proposed recommendations for genetic testing, including DTC tests.

In addition, the Federal Trade Commission in 2006 created a "Facts for Consumers" document that advised users of DTC tests to be "wary of claims about the benefits these products supposedly offer."

Although the FTC proposed no regulation specific for these tests, it was concerned that consumers would not understand the complexity of genetic testing, such as how the presence of a gene may contribute to disease risk.

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